Horizon Display Controller Part # 266-200-010
FDA 510(k) K884423 · Mennen Medical, Inc.
510(k) numberK884423
Submission
- Device name
- Horizon Display Controller Part # 266-200-010
- Applicant
- Mennen Medical, Inc.
Clarence, NY, US - Received
- October 19, 1988
- Decision date
- May 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K073140 | Vitalogik Model 4000/4500DSI · Special | 11/21/2007SE |
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Questions and answers
When was Horizon Display Controller Part # 266-200-010 cleared by the FDA?
Horizon Display Controller Part # 266-200-010 (K884423) received a 510(k) decision of Substantially Equivalent on May 31, 1989, 224 days after the submission was received.
What is the product code of K884423?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.